The present invention relates generally to the detection of leaks or faults in materials having electrical insulating properties, such as rubber or plastic surgical or examination gloves. More particularly the present invention is directed to apparatus and method for determining leaks in such a glove by establishing an electrical circuit through a leak in a glove due to the passage of ions through the leak by contacting the outer surface of the glove with a stream of ion-containing non-recirculated tap water or sterile saline solution.
Around the turn of the century, due in a large extent to work with bacteria began by Louis Pasteur, it became recognized that there is a need for protection against cross-contamination between patients and health care professionals, and subsequently between patients contacted by the health care professional. Because of this problem, many modern techniques have been developed to ensure disinfection and sterilization of instruments and equipment. Also to this end, barriers to microbes, such as gowns, face masks, and surgical or examination gloves are generally worn by the health care professional when potentially infectious conditions are encountered. More recently because of the spread of AIDS and hepatitis, health care professionals wear such barriers much more routinely than they did in the past.
Surgical or examination gloves do much to protect the health care professional from infection but are inconvenient and expensive if the gloves have to be changed between each patient. Fortunately, studies have shown that wearing rubber or plastic surgical or examination gloves, and washing the gloved hands between patients, is more effective in preventing cross-contamination between patients than is washing the hands, apparently because pores, wrinkles and the otherwise rough surface of the hands may sometimes protect trapped bacteria and viral agents from being washed away.
Because of the problems encountered in mass manufacturing and surgical or examination gloves, there is always a risk that a new glove might have a leak or undetectable micro-tear. Presently, federal regulations permit 4 out of every 100 examination gloves to have pinholes. The use, washing, and reuse of gloves tends to raise the probability that a leak or tear may develop. If a non-obvious leak or tear is present in a surgical or examination glove, the health care professional may be at risk without realizing the risk.
The leak testing of surgical gloves has been previously achieved by establishing electrical circuits through leaks in the gloves. In the use of such previous leak-testing techniques, electrical leads are directly or indirectly provided at the inner and outer surfaces of a glove to be leak tested and then the glove is immersed in a pool of ion-containing liquid such as a saline solution contained in a basin or contacted by a similar solution recirculated through the leak testing system. If a leak larger than the ions in the liquid is present in the glove, an electrical circuit is established through the leak to show that the glove is defective.
While these previous leak testing techniques may be satisfactory for leak testing surgical gloves before they are used, a significant problem arises when the gloves are checked for leaks during use or when gloves that are to be repeatedly used for medical procedures are leak tested between patients. This problem is due to the potential cross-contamination of gloves that are leak tested subsequent to the leak testing of a glove that is contaminated with one or more infectious organism since any infectious organism that have been "washed" from a tested glove supporting such organisms will be retained in the leak testing liquid contained in the basin or recirculated through the leak testing system so as to contaminate any glove that is subsequently tested for leaks.
The use of antibacterial agents in the leak testing liquid contained in the basin or recirculated through the system may possibly control some or many of the infectious organisms. However, there still remained a substantial possibility that if all the infectious organisms supported on the glove were not be controlled by the antibacterial agent the liquid in the basin or in the recirculating system would become contaminated. Also, such contamination of the liquid could also spread from the liquid to the basin or the components in the liquid recirculating system so as to create an undesirable source of contamination.